510(k) · Cleared
Recalled · Class II · 2016Target Detachable Coils
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Neurovascular · HCG Device, Neurovascular Embolization
Cleared on May 19, 2016 as substantially equivalent to K123377 (Stryker Neurovascular, 2012) after a 150-day review. Its family tree reaches back 12 generations to 1995. 11 later devices descend from it. It has been recalled 28 times.
- Decided
- May 19, 2016
- Review
- 150 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 28
- Predicates
- 1
Its longest line of descent runs back 12 generations to K951256 (1995). 38 ancestors in all, the oldest K860840 (1986). 11 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 8 generations between
- 3 generations backK112385 Traget Detachable CoilStryker Neurovascular · 2011
- 2 generations backK113412 Target Detachable CoilStryker Neurovascular · 2011 · Recalled
- 1 generation backK123377 Target Detachable CoilStryker Neurovascular · 2012
- This deviceK153658 Target Detachable CoilsStryker Neurovascular · 2016
- Descendant · cites it directly · 10 of its ownK161429 Target Detachable CoilsStryker Neurovascular · 2016
- Descendant · cites it directly · 3 of its ownK222533 Target Tetra Detachable CoilsStryker Neurovascular · 2022
- Descendant · 2 generations on · 3 of its ownK203625 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK242243 Target Detachable CoilsStryker Neurovscular · 2024
- Descendant · 3 generations on · 2 of its ownK232955 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 11 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 10 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 9 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 8 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 7 generations backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 6 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 5 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 4 generations backK102672 Target Detachable CoilBoston Scientific Corp · 2010
- 3 generations backK112385 Traget Detachable CoilStryker Neurovascular · 2011
- 2 generations backK113412 Target Detachable CoilStryker Neurovascular · 2011 · Recalled
- 1 generation backK123377 Target Detachable CoilStryker Neurovascular · 2012
- This deviceK153658 Target Detachable CoilsStryker Neurovascular · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
2016high 3 (2024) · low 0 (2017)2026
Most influential descendants
Showing 5 of 11 · See all- K161429Target Detachable CoilsStryker Neurovascular · 2016 · cites it directly10descendants
- K222533Target Tetra Detachable CoilsStryker Neurovascular · 2022 · cites it directly3descendants
- K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021 · 2 generations on3descendants
- K242243Target Detachable CoilsStryker Neurovscular · 2024 · cites it directly2descendants
- K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −11 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −10 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −9 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −8 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −7 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −6 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −5 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −4 | K102672 | Target Detachable Coil | Boston Scientific Corp | 2010 | — |
| −3 | K112385 | Traget Detachable Coil | Stryker Neurovascular | 2011 | — |
| −2 | K113412 | Target Detachable Coil | Stryker Neurovascular | 2011 | 28 |
| −1 | K123377 | Target Detachable Coil | Stryker Neurovascular | 2012 | — |
| 0 (this device) | K153658 | Target Detachable Coils | Stryker Neurovascular | 2016 | — |
| +1 | K161429 | Target Detachable Coils | Stryker Neurovascular | 2016 | — |
| +1 | K222533 | Target Tetra Detachable Coils | Stryker Neurovascular | 2022 | — |
| +2 | K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021 | — |
| +1 | K242243 | Target Detachable Coils | Stryker Neurovscular | 2024 | — |
| +3 | K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HCG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123377 | Target Detachable CoilSummary page 4…Neurovascular Embolization Devices (issued 29 Dec 2004). Legally Marketed Primary Predicate Predicate Devices: K123377, Target Detachable Coils (cleared 30 November 2012) Reference Devices… | 2012 |
| † | K093142 | Target Detachable Coils and Inzone Detachment System | 2010 |
| † | K102672 | Target Detachable Coil | 2010 |
| † | K112385 | Traget Detachable Coil | 2011 |
| † | K113412 | Target Detachable Coil | 2011 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2016 | Class II | Z-2171-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2179-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2175-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2167-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2168-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2184-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2180-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2164-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2186-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2177-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2163-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2165-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2172-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2170-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2173-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2160-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2182-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2183-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2176-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2161-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2187-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2181-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2178-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2185-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2169-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2174-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2162-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2166-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
The 5 latest of 28 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 8 of the 38 ancestors have a recall of any class.
- Of its descendants, K161429 (Stryker Neurovascular, 2016) has gone furthest, with 10 descendants of its own.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HCG
3in 2025
2007high 9 (2008) · low 1 (2019)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
2007high 173 (2018) · low 30 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
2007high 4 (2014) · low 0 (2009)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
2007high 2,494 (2017) · low 326 (2007)2025
MAUDE reports naming product code HCG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
Target Detachable Coils are indicated for endovascular embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153658: Target Detachable Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153658
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026